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Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

19. april 2011 opdateret af: Theradex

A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients.

OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: There will be 100 patients accrued into this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Oncology Center at Providence Park
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Hematology Associates, Ltd.
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
        • Highlands Oncology Group, P.A.
    • California
      • Santa Barbara, California, Forenede Stater, 93105
        • Cancer Center of Santa Barbara
    • Florida
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Good Samaritan Medical Center
    • Illinois
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital Cancer Care Institute
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131-2197
        • Creighton University Cancer Center
    • New Jersey
      • Neptune, New Jersey, Forenede Stater, 07753
        • Jersey Shore Cancer Center
    • New York
      • Albany, New York, Forenede Stater, 12209
        • Women's Health Center at Albany Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Carolinas Medical Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44302
        • Akron General Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Oncology/Hematology Care, Inc.
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Cancer Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, Forenede Stater, 17105-8700
        • Women's Cancer Center of Central PA, P.C.
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • Women and Infants Hospital of Rhode Island
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Brookview Research, Inc.
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Harrington Cancer Center
    • Washington
      • Spokane, Washington, Forenede Stater, 99202
        • Rockwood Clinic P.S.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Theradex

Efterforskere

  • Studiestol: Maurie Markman, MD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 1997

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. maj 2004

Først opslået (Skøn)

27. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. april 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2011

Sidst verificeret

1. januar 2001

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000065955
  • THERADEX-B97-3250
  • BMS-TAX/MEN.03
  • NCI-V97-1366

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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